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The First 10 Years of the European Paediatric Regulation

The conference, organized by TOPRA in collaboration with the European Commission (EC), was the opportunity to hear about the EC’s 10-year review report to the European Parliament and the Council. The report provides an account of the paediatric regulation’s achievements, both in public health and economic terms 10 years after implementation. Stakeholder representatives involved in compiling this report shared their views on the conclusions and actions for future improvements.

Delphine Kazancigil, Director, Regulatory Science, Drugs & Biologics

Delphine is an experienced regulatory science professional who has an in-depth knowledge of the European (EU) legislation and regulatory requirements. Delphine assists clients with her scientific, technical and regulatory expertise in the design of products development plans and associated regulatory and registration strategies. In particular, she has significant experience in writing pediatric investigational plans (PIP).